Part 11

No discussion of computer or control system qualification will be complete without at least an overview of Part 11 (21 CFR Part 11¹⁰). This part of the CFR has caused the pharmaceutical industry great concern in recent years due to its perceived complexity. Part 11 has been around since 1997 and is being implemented more effectively due to the revised guidelines.¹¹ According to the latest guidelines, systems put into operation prior to Aug. 1997 are considered exempt from the Part 11 rules. However, caution needs to be taken here, as any change to the system after the 1997 start, may bring the control system under Part 11 requirements.

The emphasis of Part 11 is to assure that only authorized personnel enter data, review the data, and/or change the data. All changes to the data needs to have an explanation, just as error corrections on paper require a note explaining the reason for the change. This notation is referred to as the audit trail. Care must be taken in the selection of software that includes a secure audit trail if electronic records are to be used.

Subparts B and C (of 21 CFR Part 11) represent the main body of the requirements. Only an overview of the requirements will be presented here; further study will be required to fully understand this section of the CFR.

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